Clinical Events Adjudication in the Digital Age: A Better Way to Adjudicate

January 21, 2016

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Heather Bristol, MS, is the Vice President of Informatics at Clinipace. Manejeh Yaqub, MD, is the CEC Consulting Expert.

Thank you to everyone who attended our webcast “Clinical Events Adjudication in the Digital Age.” In the presentation, we discussed when clinical events committees (CECs) are needed, CEC structures, CEC processes, what to look for when outsourcing CEC services and benefits of technology-enabled CEC processes.

If you have any additional thoughts or questions for our experts, please share your comments below.

Q: Does the FDA or any regulatory agency view electronically blinded adjudicated results more favorably than traditionally adjudicated results?

A: There are no clear regulations around this, but from a quality standpoint, in our opinion it is definitely more favorable. In addition, electronically, one can present blinded adjudications as truly independent assessments. Finally, electronically blinded adjudication provides good audit trails, which, in our opinion, are viewed more favorably by regulatory authorities.

When you have clinical research and development questions, the answer is Clearly Clinipace.

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. With personalized services and solutions, local regulatory expertise and therapeutic leadership, we overcome the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, and nephrology and urology. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach.